Contract Development & Mfg Sr Mgr jobs in United States
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Amgen · 1 day ago

Contract Development & Mfg Sr Mgr

Amgen is a leading biotechnology company focused on serving patients living with serious illnesses. The Contract Development & Mfg Sr Mgr will lead external projects for synthetic peptide and oligonucleotide development and manufacturing, ensuring compliance and efficiency while managing supplier relationships.

BiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Site Lead and project leadership for synthetic peptide and oligonucleotide external projects spanning development, clinical and commercial manufacture in close coordination with internal technical leads
Identify and establish peptide and oligonucleotide capabilities as needed
Work under minimal guidance to manage of multiple assignments and/or business processes
Build and maintain positive relationships with all Process Development functions to increase overall efficiency and success of programs
Supplier evaluation and outsourcing management including site selection activities
Develop scopes of work in close partnership with technical leads
Ensure projects and/or programs meet results, compliance, speed, quality, and cost
Manage purchase orders, financial forecasting, and associated budget for externalization to adhere to financial targets and systems
Establish and maintain external collaborations and monitor supplier performance to continuously improve efficiency and effectiveness of suppliers
Identify project optimization opportunities (e.g., timeline, budget, technical completion)
Present analyses and recommendations to Senior Management
Periodic domestic and international travel to support project results

Qualification

Synthetic therapeuticsCGMP knowledgeProject leadershipQuantitative skillsCross-functional teamworkProblem-solving skillsBusiness managementInterpersonal skillsPresentation skillsStrategic thinking

Required

Doctorate degree and 2 years of Scientific or Business Management experience
Or
Master's degree and 4 years of Scientific or Business Management experience
Or
Bachelor's degree and 6 years of Scientific or Business Management experience
Or
Associate's degree and 10 years of Scientific or Business Management experience
Or
High school diploma / GED and 12 years of Scientific or Business Management experience

Preferred

Advanced degree in engineering or science
Demonstrated understanding of drug development and commercialization for synthetic therapeutics, particularly synthetic peptides and oligonucleotides. This includes preclinical development, raw material and starting material procurement, clinical and commercial API/drug substance manufacture, process development, process engineering, process characterization and process validation
Experience working with domestic and international CMOs/CROs
Solid understanding of cGMP, Regulatory/CMC, legal, quality requirements, and import/export policies
Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multitask while consistently delivering quality results
Experienced team member of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiences
An eye for business, high-level strategic thinking, and strong problem-solving skills with the ability to structure, pragmatically scope, and solve problems
Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management
Preferred proximity to CMO and the willingness to travel if needed

Benefits

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.

Company

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.

H1B Sponsorship

Amgen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)

Funding

Current Stage
Public Company
Total Funding
$28.5B
2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO

Leadership Team

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Robert Bradway
Chairman and Chief Executive Officer
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Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
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Company data provided by crunchbase